SEPACELL R-500 AND SEPACELL R-500A— 510(k) K873792
Substantially EquivalentAdvocacy International, Ltd.
FDA 510(k) clearance K873792 for SEPACELL R-500 AND SEPACELL R-500A, Substantially Equivalent on 1988-01-19. Applicant: Advocacy International, Ltd.. Device class: 2.
Clearance details
- Applicant
- Advocacy International, Ltd.
- Product code
- Code CAK
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
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More clearances from Advocacy International, Ltd.
view allAdverse events under product code CAK
product code CAK- Malfunction
- 476
- Total
- 476
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.